Infusion device with active and passive check valves

• US 20070255261A1
• Filed: 04/27/2006
• Published: 11/01/2007
• Est. Priority Date: 04/27/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Haase, James
• Granted Patent: US 8,323,267 B2
• Time in Patent Office: Days
• US Class Current: 604/891.100
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2473 Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
• CPC Class Codes: A61M 2039/248 Ball-valve
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

An infusion system in which therapeutic substance from a reservoir is pumped by a bolus pump to an infusion port is disclosed. The therapeutic substance delivered by the bolus pump passes first through a passive check valve located downstream from the pump. The passive check valve opens in response to fluid pressure of the therapeutic substance. After passing through the passive check valve, the therapeutic substance passes through an active check valve located downstream from the passive check if the active check valve is actuated such that it is open. When not activated, the active check valve is closed and fluid flow through the active check valve in the downstream direction is prevented.

Claims

1. An implantable therapeutic substance infusion device comprising:

a therapeutic substance reservoir;

control electronics operably connected to a power source;

a bolus pump operably connected to the power source and the control electronics, the bolus pump further operably connected to the reservoir and configured to pump a therapeutic substance from the therapeutic substance reservoir in a downstream direction from the bolus pump to an infusion port in response to a pump signal received from the control electronics;

a passive check valve located in a fluid pathway between the infusion port and the bolus pump, the passive check valve comprising a normally closed valve that opens in response to fluidic pressure generated by operation of the bolus pump; and

an active check valve located in the fluid pathway between the passive check valve and the infusion port, wherein the active check valve comprises a normally closed valve that opens in response to an open signal from the control electronics, and wherein fluid flow in the downstream direction through the active check valve is prevented when the active check valve is closed.

2. A device according to claim 1, wherein the fluid pathway comprises an upstream direction from the infusion port to the bolus pump, and wherein the passive check valve closes in response to fluid flow in the upstream direction.

3. A device according to claim 1, wherein the active check valve comprises a solenoid check valve.

4. A device according to claim 3, wherein the solenoid check valve comprises one or more fluid passages formed therethrough.

5. A device according to claim 4, wherein the one or more fluid passages comprises a bore formed through at least a portion of an actuator of the solenoid check valve.

6. A device according to claim 1, wherein fluid pressure on an upstream side of the active check valve increases the energy required to open the active check valve.

7. A device according to claim 1, wherein the passive check valve comprises a cracking pressure higher than a reservoir pressure of the therapeutic substance in the reservoir.

8. A device according to claim 1, wherein the passive check valve is integral with the bolus pump.

9. A device according to claim 1, wherein the bolus pump comprises a solenoid-activated piston pump.

10. A device according to claim 1, further comprising an implantable biocompatible housing, wherein the power source, control electronics, bolus pump, passive check valve, and active check valve are contained within the housing.

11. An implantable therapeutic substance infusion device comprising:

a therapeutic substance reservoir;

control electronics operably connected to a power source;

a bolus pump operably connected to the power source and the control electronics, the bolus pump further operably connected to the reservoir and configured to pump a therapeutic substance from the therapeutic substance reservoir in a downstream direction from the bolus pump to an infusion port in response to a pump signal received from the control electronics;

a passive check valve located in a fluid pathway between the infusion port and the bolus pump, the passive check valve comprising a normally closed valve that opens in response to fluidic pressure generated by operation of the bolus pump;

a solenoid check valve located in the fluid pathway between the passive check valve and the infusion port, the solenoid check valve comprising a normally closed valve that opens in response to an open signal from the control electronics, wherein fluid flow in the downstream direction through the solenoid check valve is prevented when the solenoid check valve is closed, and wherein fluid pressure on an upstream side of the solenoid check valve increases the energy required to open the solenoid check valve; and

an implantable biocompatible housing, wherein the power source, control electronics, bolus pump, passive check, valve, and solenoid check valve are contained within the housing.

12. A method of operating an implantable therapeutic substance infusion device, the method comprising:

providing an implantable therapeutic substance infusion device comprising;

a therapeutic substance reservoir;

control electronics operably connected to a power source;

a bolus pump operably connected to the power source and the control electronics, the bolus pump further operably connected to the therapeutic substance reservoir and configured to pump a therapeutic substance from the therapeutic substance reservoir in a downstream direction from the bolus pump to an infusion port;

a passive check valve located in a fluid pathway between the infusion port and the bolus pump, the passive check valve comprising a normally closed valve that opens in response to fluidic pressure generated by operation of the bolus pump; and

an active check valve located in the fluid pathway between the passive check valve and the infusion port, the active check valve comprising a normally closed valve that opens when actuated by the control electronics, wherein fluid flow in the downstream direction through the active check valve is prevented when the active check valve is closed;

actuating the bolus pump to move a bolus of therapeutic substance in the downstream direction, whereby the passive check valve opens in response to pressure exerted on an upstream side of the passive check valve by the bolus of therapeutic substance; and

opening the active check valve, whereby the bolus of therapeutic substance passes through the active check valve towards the infusion port.

13. A method according to claim 12, wherein the active check valve is open during at least a portion of the time the bolus pump is actuated.

14. A method according to claim 12, further comprising opening the active check valve before actuating the bolus pump.

15. A method according to claim 12, further comprising holding the active check valve open until the bolus of therapeutic substance passes through the active check valve.

16. A method according to claim 12, wherein the fluid pathway comprises an upstream direction from the infusion port to the bolus pump, and wherein the passive check valve closes in response to fluid flow in the upstream direction.

17. A method according to claim 12, wherein the active check valve comprises a solenoid check valve, and wherein opening the active check valve comprise energizing a coil in the solenoid check valve.

18. A method according to claim 17, wherein the solenoid check valve comprises one or more fluid passages formed therethrough, wherein the bolus of therapeutic substance passes through the one or more fluid passages when passing through the solenoid check valve towards the infusion port.

19. A method according to claim 18, wherein the one or more fluid passages comprises a bore formed through at least a portion of an actuator of the solenoid check valve.

20. A method according to claim 12, wherein the passive check valve comprises a cracking pressure higher than a reservoir pressure of the therapeutic substance in the reservoir.

21. A method according to claim 12, wherein the bolus pump comprises a solenoid-activated piston pump.

22. A method according to claim 12, further comprising an implantable biocompatible housing, wherein the power source, control electronics, bolus pump, passive check valve, and active check valve are contained within the housing.

23. A method of operating an implantable therapeutic substance infusion device, the method comprising:

providing an implantable therapeutic substance infusion device comprising;

a therapeutic substance reservoir;

control electronics operably connected to a power source;

a bolus pump operably connected to the power source and the control electronics, the bolus pump further operably connected to the therapeutic substance reservoir and configured to pump a therapeutic substance from the therapeutic substance reservoir in a downstream direction from the bolus pump to an infusion port;

a passive check valve located in a fluid pathway between the infusion port and the bolus pump, the passive check valve comprising a normally closed valve that opens in response to fluidic pressure generated by operation of the bolus pump;

a solenoid check valve located in the fluid pathway between the passive check valve and the infusion port, the solenoid check valve comprising a normally closed valve that opens when actuated by the control electronics, wherein the solenoid check valve comprises one or more fluid passages formed therethrough, and wherein fluid flow in the downstream direction through the solenoid check valve is prevented when the solenoid check valve is closed, and further wherein fluid pressure on an upstream side of the solenoid check valve increases the energy required to open the solenoid check valve; and

an implantable biocompatible housing, wherein the power source, control electronics, bolus pump, passive check valve, and solenoid check valve are contained within the housing;

actuating the bolus pump to move a bolus of therapeutic substance in the downstream direction, whereby the passive check valve opens in response to pressure exerted on an upstream side of the passive check valve by the bolus of therapeutic substance; and

opening the solenoid check valve by energizing a coil, whereby the bolus of therapeutic substance passes through the one or more fluid passages in the solenoid check valve towards the infusion port.